Diaper rash is an inflammation of the skin in the diaper area of neonates, infants, children, and incontinent adults. It is generally believed caused by the metabolic by-products of both urine and feces. Currently available treatments for diaper rash are generally based upon the use of zinc oxide, vitamins (A, D, and D.sub.3), or some combination thereof. These active ingredients are incorporated into a cream or salve by blending them into various purified semisolid ointment bases, e.g. mineral oil, petrolatum, soft paraffin, lanolin, and the like. While these treatments are oftentimes effective for treating routine, simple diaper rashes, severe cases of diaper rash, especially those often observed with incontinent adults, have proved resistant to the treatments.
Accordingly, there is a need for an improved diaper rash treatment, particularly for use in severe cases.
The primary component of the compositions used herein for the improved treatment of diaper rash is a copolymer of a lower alkyl vinyl ether and maleic acid. U.S. Pat. Nos. 3,003,988 and 4,393,080 disclose the use of the copolymer and derivatives thereof as an adhesive for fixing dentures or ostomy devices to mucous membranes. U.S. Pat. No. 4,910,247 discloses a blend of a mixed salt of the copolymer in combination with a stearic acid metal salt as an improved adhesive for denture and ostomy use. U.S. Pat. No. 3,876,771 discloses a skin protection gel for use in protecting a stoma from fecal matter and still active gastric juices, which gel contains 25 to 95% isopropanol along with the monoisopropyl ester of the copolymer. U.S. Pat. No. 4,007,263 discloses a method of relieving irritation of skin (due to fecal drainage) surrounding an iliac stoma by applying thereto a composition containing at least 40% of a calcium, sodium partial mixed salt of the copolymer in a petroleum jelly base. U.S. Pat. No. 4,728,642 discloses a method of treating wounds by packing a wound emitting a large amount of fluid with granular material and then covering the wound site with an adhesive layer containing in part the copolymer or a derivative thereof. European Appln. 0,260,859 discloses a medicated skin composition containing the copolymer, isopropyl alcohol, citric acid ester plasticizer, and a specific antimicrobial agent.
Accordingly, the copolymer and its derivatives, while having been found to have utility as an adhesive, for protecting and relieving irritation from fecal matter (normally neutral or slightly alkaline) around a stoma, as part of an adhesive layer over a wound, and as a carrier/adhesive for an antimicrobial agent, has not been used as a treatment for diaper rash or to relieve skin irritation caused by contact with urine (normally slightly acidic), its metabolic by-products, infant feces (usually acidic), and its metabolic by-products.
It is thus an object of the present invention to produce a treatment for and inhibition of diaper rash in neonates, infants, children, and incontinent adults, which treatment is effective even in severe cases of diaper rash.